Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.

Study Overview

• Status: Completed
• Conditions: Sepsis; Healthy; Septic Shock
• Intervention / Treatment: Device: Blood collection

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Mercy Health St. Vincent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

150 generally healthy adults. This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.

Description

Inclusion Criteria:

1. Male or female, aged ≥ 18 years.
2. Apparently healthy as determined by a subject questionnaire.

Exclusion Criteria:

1) Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:

1. Heart disease
2. Stroke
3. Renal disease
4. Liver disease
5. Pancreatic disease
6. Chronic obstructive pulmonary disorder
7. Bleeding disorders
8. Hypercalcitoninemia
9. HIV AIDS
10. Receiving antibiotic therapy
11. Suspected infection

12. Immunosuppression

    2) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.

    3) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.

    4) Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.

    5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care.

    6) Current diagnosis of cancer within the last 12 months.

    7) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.

    8) Hospitalization for more than 24 hours within the last 3 months.

    9) Reported as currently pregnant or nursing a child

    10) Unable or unwilling to provide the required blood sample for testing.

    11) Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interventions; This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.	Device: Blood collection; 9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of reference range interval of PSP	To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect medical data of healthy volunteer	To collect medical data from the 150 study participants using a volunteer questionnaire	Day 1
Obtain well characterised samples library to be used for future tests development	Whole blood collection from 150 healthy subject to be used for future tests development.	Day 1

Collaborators and Investigators

• Sponsor: Abionic SA
• Collaborators: Boston Biomedical Associates; Ocean State Clinical Coordinating Center

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Sepsis; Immunoassay; Pancreatic Stone Protein; Point-of-care device; Abionic; Healthy population
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: AB-PSP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes